Résumé
GIAPREZA 2.5 mg/mL concentrate for infusion is a hospital specialty based on angiotensin II, indicated in the treatment of refractory hypotension in adults with septic shock or any other distributive shock with persistent hypotension despite filling. adequate vascularization, administration of catecholamines and other available vasopressors.
GIAPREZA comes in a solution to be diluted before use. The diluted solution is administered by continuous intravenous infusion.
Blood pressure should be monitored at the initiation of treatment to adjust the dosage, then during treatment.
When stopping treatment, the dose should be reduced gradually to avoid hypotension or worsening of the diagnosis of shock following abrupt or premature discontinuation.
GIAPREZA is intended for hospital use only. It is approved for communities.
Lhe specialty GIAPREZA 2.5 mg/mL concentrate for solution for infusion (angiotensin II acetate) is indicated in the treatment of refractory hypotension in adults presenting with septic shock or any other distributive (or vasoplegic) shock with persistent hypotension despite a adequate vascular filling, administration of catecholamines and other available vasopressors.
GIAPREZA is a medicine reserved for hospital use.
It is subject to additional monitoring which will enable the rapid identification of new safety-related information. Healthcare professionals report any suspected adverse reactions.
A last resort alternative
The superiority of angiotensin II compared to placebo was demonstrated in the phase III ATHOS-3 study, only on the following intermediate endpoint:
- increase in mean arterial pressure to at least 75 mmHg or increase from baseline of at least 10 mmHg 3 h after initiation of treatment.
In this study, angiotensin was administered in addition to catecholamines and/or other vasopressors in 321 adult patients in distributive shock with refractory hypotension.
As a reminder, four main categories of shock states are described:
- distributive or vasoplegic shock (66%);
- hypovolemic shock (16%);
- cardiogenic shock (16%);
- and obstructive shock (2%).
Distributive shock includes septic and non-septic shock states (anaphylactic, neurogenic, spinal, etc.).
Based on this study, the Transparency Commission (CT) awarded GIAPREZA a moderate actual benefit (SMR). According to the conclusions of the CT [1] :
- GIAPREZA constitutes a therapeutic alternative of last resort in the treatment of refractory hypotension in adults presenting septic shock or any other distributive shock with persistent hypotension despite adequate vascular filling, administration of catecholamines and other available vasopressors;
- GIAPREZA does not provide any improvement in actual benefit (ASMR V) in the current therapeutic strategy of last resort for the treatment of refractory hypotension in adults presenting with septic shock or any other distributive shock despite adequate vascular filling and after administration of catecholamines and other available vasopressors.
In practice
Dilution avant injection
GIAPREZA comes in a 1 mL bottle of solution to be diluted before use. The dilution is carried out in a 9 mg/mL (0.9%) sodium chloride injection solution following the procedure described in the summary of product characteristics (SPC).
Dosage recommendations: initiation and discontinuation of treatment
The recommended starting dose of GIAPREZA is 20 nanograms (ng)/kg per minute continuous intravenous (IV) infusion. The use of a central venous catheter is recommended.
Once the infusion is initiated, it is important to monitor blood pressure. The dose may be adjusted gradually every 5 minutes, in increments not exceeding 15 ng/kg per minute, depending on the patient’s condition and target mean arterial pressure.
It is important to administer GIAPREZA at the lowest effective dose to achieve or maintain adequate blood pressure and tissue perfusion.
To minimize the risk of adverse effects related to prolonged vasoconstriction, treatment should be stopped as soon as the underlying shock has sufficiently improved.
When stopping treatment, the dose should be reduced gradually up to 15 ng/kg per minute, as needed, based on blood pressure, to avoid hypotension following abrupt cessation.
Administrative identity
List I
Reserved for hospital use
Medicine that can be administered by any doctor intervening in an emergency situation or as part of a mobile medical assistance or medical repatriation structure (article R.5121-96 of the Public Health Code)
Box of 10 vials of 1 mL, CIP 3400955095330
Approval for communities [2]
Viatris Health Laboratory
